UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058723 |
|---|---|
| Receipt number | R000064781 |
| Scientific Title | Verification of the effectiveness of a remote monitoring training system devised to combat frailty in community-dwelling elderly people |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 14:32:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intervention study to prevent frailty in community-dwelling elderly people
Acronym
Intervention study targeting community-dwelling elderly people
Scientific Title
Verification of the effectiveness of a remote monitoring training system devised to combat frailty in community-dwelling elderly people
Scientific Title:Acronym
Verification of the effectiveness of a training system devised to combat frailty among community-dwelling elderly people
Region
| Japan |
Condition
Condition
Community-dwelling elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will examine whether implementing an exercise program we have devised for elderly facility residents who are at risk of becoming frail will have effects such as increasing skeletal muscle mass, improving physical ability, and extending the period of independence in activities of daily living (ADL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Activities of daily living and cognitive function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Training (resistance training + balance training)
Interventions/Control_2
Training 2 (Stretching)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. People between 65 and 85 years of age at the time of study enrollment
2. People who own a smartphone and can watch YouTube freely (regardless of place, time, etc.) at their own discretion
3. People who can watch YouTube (videos) for about 15 minutes a day on their smartphone for 48 weeks (communication fees and expenses must be borne by the participant)
4. People who are able to walk (walking with the aid of a wheelchair or walking stick is acceptable)
Key exclusion criteria
1. Individuals with reduced walking ability and restrictions on daily living activities (those who fall into category III on the DASC-8)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noya |
| Middle name | |
| Last name | Yahagi |
Organization
Jichi Medical University
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
TEL
0285-58-7355
nyahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba
Division name
Systems and Information Engineering
Zip code
3058573
Address
1-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
0298536181
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
university of tsukuba
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture, 329-0498
Tel
0285-58-7355
yasuhiro@ai.iit.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064781
